Job Opportunity
We are seeking a highly skilled Senior Manager to lead our document and process management efforts.
Key Responsibilities
* Develop business requirements for CTMS management, ensuring quality, completeness, and timeliness of study, country, and site operational data.
* Identify interdependencies with other relevant CTMS modules/capabilities to streamline clinical trial operations.
* Create and manage control documents and supporting materials to ensure repeatable, predictable, and scalable business processes.
* Collaborate with cross-functional teams to gather feedback and understand needs to identify valuable improvements.
* Drive continuous improvement by shaping CTMS strategies to align with evolving industry standards and regulations.
* Monitor CTMS metrics and address performance, data quality, and usability issues in a timely manner.
* Provide and continuously improve CTMS training, support user community, and maintain resources like FAQs and communication plans.
Technology & Process Enhancement
The successful candidate will advocate for the introduction and integration of innovative technologies that bolster our document management and communication operations.
Leadership & Team Collaboration
The Senior Manager will lead and support CTMS-related meetings, including Superuser and Operational Working Group, and present to stakeholders as needed.
Requirements
* Relevant experience with Clinical Trials, documents, and responsibilities internal and external to the organization.
* Subject Matter Expertise in CTMS, TMF, and Organization/Person Profile Management.
* Ability to communicate complex issues to internal and external partners driving effective decision-making.
* Proven experience in a multi-disciplinary environment.